NCT07465588

Brief Summary

This study tests whether providing financial rewards based on a blood test result can help people with alcohol-associated liver disease (ALD) stop or reduce their drinking. The blood test is called phosphatidylethanol (PEth), which can detect alcohol use over the past three to four weeks. The financial reward program is called contingency management (CM). The study has two parts. Part 1 involves one-time interviews and surveys with patients and healthcare providers to understand how a PEth-based CM program could best be delivered in a liver disease clinic. Part 2 is a pilot randomized controlled trial (the REINFORCE Trial) in which participants are randomly assigned to one of two groups: (1) a rewards group that receives escalating financial incentives when PEth results show reduced or no alcohol use, or (2) a monitoring group that receives fixed payments regardless of PEth results. Both groups receive PEth testing and continue their usual medical care. The study will assess whether the rewards program improves alcohol abstinence and reduction at 12 and 24 weeks.'

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
23mo left

Started Aug 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Aug 2026Jun 2028

First Submitted

Initial submission to the registry

March 6, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 12, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

1.7 years

First QC Date

March 6, 2026

Last Update Submit

March 10, 2026

Conditions

Alcohol Use DisorderAlcohol-associated Liver DiseaseLiver Cirrhosis, AlcoholicAlcohol-Associated Hepatitis

Keywords

Contingency ManagementPhosphatidylethanolPEthDried Blood SpotAlcohol BiomarkerAlcohol AbstinenceHepatologyLiver DiseaseFinancial IncentivesBehavioral Intervention

Outcome Measures

Primary Outcomes (1)

  • Alcohol Abstinence Measured by PEth

    Alcohol abstinence measured using phosphatidylethanol (PEth) levels obtained from dried blood spot testing. PEth is a validated biomarker of recent alcohol consumption. The primary outcome is the proportion of participants with PEth levels consistent with alcohol abstinence during the intervention period.

    12 weeks

Secondary Outcomes (4)

  • Changes in Alcohol Use Measured by PEth

    Baseline to 12 weeks

  • Intervention Feasibility

    12 weeks

  • Participant Acceptability of the Intervention

    12 weeks

  • Sustained Alcohol Abstinence After Intervention

    24 weeks

Study Arms (2)

Contingency Management Intervention

EXPERIMENTAL

Participants receive a PEth based contingency management intervention designed to promote alcohol abstinence. Participants undergo serial phosphatidylethanol (PEth) testing using dried blood spot samples. Financial incentives are provided contingent on alcohol abstinence or significant reduction in alcohol use as measured by PEth levels. The intervention lasts 12 weeks with follow up through 24 weeks.

Behavioral: PEth Based Contingency Management

PEth Monitoring Control

ACTIVE COMPARATOR

Participants undergo the same schedule of PEth testing using dried blood spot samples but receive fixed incentives that are not contingent on alcohol use outcomes. This arm controls for monitoring and compensation while isolating the behavioral effect of contingency management.

Behavioral: PEth Monitoring with Fixed Incentives

Interventions

PEth Based Contingency ManagementBEHAVIORAL

Participants receive a contingency management intervention designed to promote alcohol abstinence among patients with alcohol use disorder and alcohol associated liver disease. Alcohol use is monitored using serial phosphatidylethanol (PEth) testing from dried blood spot samples. Participants receive financial incentives contingent on alcohol abstinence or substantial reduction in alcohol consumption as measured by PEth levels. Incentives escalate with consecutive negative PEth results during the 12 week intervention period.

Also known as: Contingency Management for Alcohol Abstinence
Contingency Management Intervention
PEth Monitoring with Fixed IncentivesBEHAVIORAL

Participants undergo serial phosphatidylethanol (PEth) testing using dried blood spot samples at the same schedule as the intervention group. Participants receive fixed incentives for completing testing visits, but incentives are not contingent on alcohol use outcomes. This condition controls for study participation, monitoring, and compensation while isolating the effect of contingency management.

Also known as: PEth Monitoring Control
PEth Monitoring Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18 years or older
  • Diagnosis of alcohol use disorder based on DSM 5 criteria
  • Diagnosis of alcohol associated liver disease or clinically suspected alcohol related liver injury
  • Evidence of recent alcohol use or at risk for alcohol relapse
  • Receiving care in hepatology or liver disease clinic at the participating institution
  • Willingness to undergo serial phosphatidylethanol (PEth) testing using dried blood spot samples
  • Ability to provide informed consent
  • Willingness to participate in the contingency management intervention and follow study procedures

You may not qualify if:

  • Severe cognitive impairment or medical condition that prevents participation in study procedures
  • Active psychosis or severe psychiatric instability that would interfere with participation
  • Current enrollment in another contingency management program targeting alcohol use
  • Medical instability requiring hospitalization at the time of enrollment
  • Inability to communicate in English (if study materials are only available in English)
  • Any condition that, in the opinion of the investigators, would make participation unsafe or interfere with completion of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • Crabb DW, Im GY, Szabo G, Mellinger JL, Lucey MR. Diagnosis and Treatment of Alcohol-Associated Liver Diseases: 2019 Practice Guidance From the American Association for the Study of Liver Diseases. Hepatology. 2020 Jan;71(1):306-333. doi: 10.1002/hep.30866. No abstract available.

    PMID: 31314133BACKGROUND

  • Beck O, Kenan Moden N, Seferaj S, Lenk G, Helander A. Study of measurement of the alcohol biomarker phosphatidylethanol (PEth) in dried blood spot (DBS) samples and application of a volumetric DBS device. Clin Chim Acta. 2018 Apr;479:38-42. doi: 10.1016/j.cca.2018.01.008. Epub 2018 Jan 5.

    PMID: 29309773BACKGROUND

  • Edelman EJ, Dziura J, Deng Y, DePhilippis D, Fucito LM, Ferguson T, Bedimo R, Brown S, Marconi VC, Goetz MB, Rodriguez-Barradas MC, Simberkoff MS, Molina PE, Weintrob AC, Maisto SA, Paris M, Justice AC, Bryant KJ, Fiellin DA. Contingency management with stepped care for unhealthy alcohol use among individuals with HIV: Protocol for a randomized controlled trial. Contemp Clin Trials. 2023 Aug;131:107242. doi: 10.1016/j.cct.2023.107242. Epub 2023 May 23.

    PMID: 37230168BACKGROUND

  • Petry NM, Alessi SM, Olmstead TA, Rash CJ, Zajac K. Contingency management treatment for substance use disorders: How far has it come, and where does it need to go? Psychol Addict Behav. 2017 Dec;31(8):897-906. doi: 10.1037/adb0000287. Epub 2017 Jun 22.

    PMID: 28639812BACKGROUND

  • Lee BP, Witkiewitz K, Mellinger J, Anania FA, Bataller R, Cotter TG, Curtis B, Dasarathy S, DeMartini KS, Diamond I, Diazgranados N, DiMartini AF, Falk DE, Fernandez AC, German MN, Kamath PS, Kidwell KM, Leggio L, Litten R, Louvet A, Lucey MR, McCaul ME, Sanyal AJ, Singal AK, Sussman NL, Terrault NA, Thursz MR, Verna EC, Radaeva S, Nagy LE, Mitchell MC. Designing clinical trials to address alcohol use and alcohol-associated liver disease: an expert panel Consensus Statement. Nat Rev Gastroenterol Hepatol. 2024 Sep;21(9):626-645. doi: 10.1038/s41575-024-00936-x. Epub 2024 Jun 7.

    PMID: 38849555BACKGROUND

  • Jett JD, Beck R, Tyutyunnyk D, Sanchez J, Weeks DL, Javors MA, Hill-Kapturczak N, Lopez-Cruzan M, Kriegel L, Ginsburg BC, Cabassa L, McDonell MG. Feasibility of a telehealth-based contingency management intervention for alcohol use disorders using the phosphatidylethanol (PEth) 16:0/18:1 alcohol biomarker: a pilot randomized trial. Am J Drug Alcohol Abuse. 2024 Mar 3;50(2):162-172. doi: 10.1080/00952990.2023.2283691. Epub 2024 Jan 29.

    PMID: 38284925BACKGROUND

  • McDonell MG, Skalisky J, Leickly E, Orr MF, McPherson S, Roll J, Hill-Kapturczak N, Javors M. Pilot investigation of a phosphatidylethanol-based contingency management intervention targeting alcohol use. Psychol Addict Behav. 2017 Aug;31(5):608-613. doi: 10.1037/adb0000293. Epub 2017 Jul 17.

    PMID: 28714726BACKGROUND

MeSH Terms

Conditions

AlcoholismLiver Cirrhosis, AlcoholicAlcohol AbstinenceLiver Diseases

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersLiver CirrhosisDigestive System DiseasesLiver Diseases, AlcoholicFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsAlcohol-Induced DisordersDrinking BehaviorBehavior

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Central Study Contacts

Wei Zhang, MD PHD

CONTACT

16177265925wzhang50@mgh.harvard.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
This is an open label behavioral intervention study. Participants and investigators are aware of group assignment because incentives in the intervention group are contingent on PEth results.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study is a two arm randomized controlled trial evaluating a phosphatidylethanol (PEth) based contingency management intervention for alcohol abstinence among patients with alcohol associated liver disease and alcohol use disorder. Participants will be randomized in a 1:1 ratio to either a contingency management intervention group or a control group receiving PEth monitoring with fixed incentives. The intervention period is 12 weeks with follow up through 24 weeks.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine, Harvard Medical School

Study Record Dates

First Submitted

March 6, 2026

First Posted

March 12, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

June 30, 2028

Last Updated

March 12, 2026

Record last verified: 2026-03